NCT00897754

Brief Summary

RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors understand how patients respond to treatment. PURPOSE: This laboratory study is looking at gene expression in patients with advanced or metastatic colorectal cancer receiving bevacizumab.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2007

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 24, 2007

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 9, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 12, 2009

Completed
Last Updated

May 19, 2017

Status Verified

May 1, 2017

Enrollment Period

1.5 years

First QC Date

May 9, 2009

Last Update Submit

May 17, 2017

Conditions

Keywords

adenocarcinoma of the colonadenocarcinoma of the rectumrecurrent rectal cancerstage III rectal cancerstage IV rectal cancerrecurrent colon cancerstage III colon cancerstage IV colon cancer

Outcome Measures

Primary Outcomes (4)

  • Mean scores for VEGFb and pan-VEGF gene expression by IHC

    1 month

  • Gene expression as measured by tissue microarrays

    1 month

  • Splice form expression as measured by reverse transcriptase-PCR

    1 month

  • VEGF165b protein expression as measured by ELISA

    1 month

Interventions

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Samples submitted for research from patients participating in E3200

DISEASE CHARACTERISTICS: * Tumor tissue samples available from patients with advanced or metastatic adenocarcinoma of the colon or rectum * Receiving bevacizumab on clinical trial E-3200 PATIENT CHARACTERISTICS: * Not specified PRIOR CONCURRENT THERAPY: * See Disease Characteristics

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

Colorectal NeoplasmsColonic NeoplasmsRectal Neoplasms

Interventions

Gene Expression ProfilingReverse Transcriptase Polymerase Chain ReactionImmunoenzyme TechniquesImmunohistochemistryImmunologic Techniques

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Genetic TechniquesInvestigative TechniquesPolymerase Chain ReactionNucleic Acid Amplification TechniquesImmunoassayMolecular Probe TechniquesHistocytochemistryCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisHistological Techniques

Study Officials

  • David Bates, PhD

    Bristol Heart Institute at University of Bristol

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2009

First Posted

May 12, 2009

Study Start

July 24, 2007

Primary Completion

February 1, 2009

Study Completion

February 1, 2009

Last Updated

May 19, 2017

Record last verified: 2017-05